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Downstream Manufacturing Associate (Multiple Levels & Roles)

4+ years
Not Disclosed
10 Jan. 2, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Downstream Manufacturing Associate (Multiple Levels & Roles)
Company: Enzene
Location: Hopewell, New Jersey, United States

About Enzene
Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a robust operational presence in India. As a subsidiary of Enzene Biosciences, a leading biotechnology company, Enzene is committed to delivering high-quality biologics manufacturing services to clients and contributing to the advancement of the pharmaceutical industry.

Website: www.enzene.com

Position Overview
The Downstream Manufacturing Associate will be responsible for the day-to-day operations of downstream processing in a clean room environment. The role involves buffer and media preparation, chromatography, tangential flow filtration (TFF), viral filtration, and aseptic processing. The position can vary depending on the level, from hands-on operations to leadership responsibilities.

Key Responsibilities

  • Buffer and Media Preparation: Prepare and maintain buffers and media required for downstream processes. Ensure accurate formulation and timely availability of solutions, maintaining detailed records of preparation and usage.
  • Chromatography: Operate and maintain chromatography systems for protein purification, ensuring consistent product quality. Troubleshoot and resolve issues during chromatography runs.
  • Tangential Flow Filtration (TFF): Perform TFF operations for concentration and diafiltration of biopharmaceutical products. Optimize parameters to achieve desired product specifications and document activities.
  • Viral Filtration: Conduct viral filtration to ensure product safety and purity. Validate processes and maintain compliance with regulatory standards for viral safety.
  • Aseptic Processing: Perform aseptic processing in a clean room environment, adhering to strict techniques to prevent contamination while ensuring GMP compliance.
  • Clean Room Operations: Maintain a clean and organized work environment, follow all clean room protocols, and participate in regular cleaning and maintenance activities.
  • Documentation and Compliance: Ensure accurate records of all manufacturing activities and compliance with GMP and regulatory requirements. Participate in audits and inspections as required.
  • Leadership (as appropriate for the role): Lead daily manufacturing operations to meet production targets while maintaining high quality standards. Ensure team adherence to SOPs, GMP, and safety regulations. Provide training, guidance, and feedback to team members, leading and mentoring for effective performance and continuous improvement.

Qualifications

  • Education and Experience: Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, or a related field (0+ years of experience for junior roles). For senior roles, 4+ years of relevant experience required (H.S. diploma with 4+ years of experience considered in lieu of a Bachelor’s degree).
  • Skills: Ability to follow instructions and procedures. Experience in buffer/media preparation, chromatography, TFF, viral filtration, and aseptic processing is a plus. Strong problem-solving, analytical skills, and effective communication and leadership abilities. Knowledge and experience in a biopharmaceutical cGMP-regulated environment. Ability to stand for long periods, bend, and lift up to 50 pounds.

Why Join Enzene?
At Enzene, we offer a collaborative and innovative environment where science and business intersect. Our team is dedicated to advancing biosimilar manufacturing, striving to improve processes and patient outcomes. Joining Enzene means becoming part of a company that values integrity, innovation, and collaboration. We provide an environment conducive to growth, learning, and opportunity in a healthcare sector driving change.

Equal Opportunity Employer
Enzene is an equal opportunity employer, committed to fostering a diverse and inclusive work environment where all employees can thrive.